Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

March 16, 2011 updated by: Drexel University

An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas

The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

11

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 Years or Older
  • Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
  • Karnofsky performance status > 70%
  • Hemoglobin > 10.0 g/dL, White Blood Cells > 4,000/mm3, Platelets > 100,000/mm3, BUN < 25 mg/dL, Creatinine < 1.5 mg/dL
  • Signed informed consent
  • Pathologic confirmation of GBM or AAF
  • A negative beta hCG test for women of childbearing potential
  • Negative HAMA test

Exclusion Criteria:

  • Metastases or Second Primary Cancer
  • Iodine allergy
  • Inability to tolerate oral intake of Lugol's solution
  • HIV Infection
  • Positive HAMA test
  • Pregnancy
  • Uncontrolled Seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treated with MAB-425
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
Drug: MAB-425 radiolabeled with I-125
MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of disease progression
Time Frame: 3 months after first course with follow-up
For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline
3 months after first course with follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (ESTIMATE)

March 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 16, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18508
  • 1043323 (OTHER: Drexel University College of Medicine IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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